Type 2 DiabetesNCT05822648
Evaluating a Type 2 Diabetes Prevention Program
A study testing Project Health in people with Type 2 Diabetes and PreDiabetes, run by Stanford University at 1 site in United States.
Trial summary
This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes
- What is being tested?
- Project Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65
- Overweight (BMI between 25 and 40 kg/m2)
- Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Who cannot join
- Not between the ages of 18 and 65
- Not overweight (BMI between 25 and 40 kg/m2)
- Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability
This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.
- Conditions
- Type 2 Diabetes, PreDiabetes
- Being tested
- Project Health, Educational Video Control
- Keywords
- prevention, Type 2 Diabetes, prediabetes, group intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project HealthBehavioural
Project Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle.
Educational Video ControlOther
We selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Project Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle. Receives: Behavioral: Project Health |
| Control | Active comparator | We selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan Receives: Other: Educational Video Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI) - Post-Test
BMI will be assessed at post-test to see which intervention produced greater reductions in BMI
Measured: post-test (immediately after completion of 6 week intervention)
Body Mass Index (BMI) - 3-Month Follow-Up
BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI
Measured: 3-month follow-up
HbA1c at 3-month Follow-up
Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status
Measured: 3-month follow-up
Fasting Plasma Glucose
Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status
Measured: 3-month follow-up
Percent Body Fat - Post-Test
Measured: post-test (immediately after completion of 6 week intervention)
Percent Body Fat - 3-Month Follow-Up
Measured: 3-month follow-up
Percent Lean Body Mass - Post-Test
Measured: post-test (immediately after completion of 6 week intervention)
Percent Lean Body Mass - 3-Month Follow-Up
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start15 Apr 2023
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Stice, Stanford University
- Investigators
- Eric Stice, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822648
- Sponsor's protocol ID
- 68320
- Other IDs
- P30DK116074
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2023
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability
- ClinicalTrials.gov ID
- NCT05822648
- Acronym / sponsor ID
- 68320
- Conditions
- Type 2 Diabetes, PreDiabetes
- Keywords
- prevention, Type 2 Diabetes, prediabetes, group intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Project HealthProject Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle. |
| Control | Active comparator | Other: Educational Video ControlWe selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 65
- Overweight (BMI between 25 and 40 kg/m2)
- Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Key exclusion criteria (3 listed)
- Not between the ages of 18 and 65
- Not overweight (BMI between 25 and 40 kg/m2)
- Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project HealthProject Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle. | Behavioural | Intervention |
| Educational Video ControlWe selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan | Other | Control |
Primary outcome
Body Mass Index (BMI) - Post-Test
Time frame: post-test (immediately after completion of 6 week intervention)
BMI will be assessed at post-test to see which intervention produced greater reductions in BMI
Body Mass Index (BMI) - 3-Month Follow-Up
Time frame: 3-month follow-up
BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI
HbA1c at 3-month Follow-up
Time frame: 3-month follow-up
Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status
Fasting Plasma Glucose
Time frame: 3-month follow-up
Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status
Percent Body Fat - Post-Test
Time frame: post-test (immediately after completion of 6 week intervention)
Percent Body Fat - 3-Month Follow-Up
Time frame: 3-month follow-up
Percent Lean Body Mass - Post-Test
Time frame: post-test (immediately after completion of 6 week intervention)
Percent Lean Body Mass - 3-Month Follow-Up
Time frame: 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Stice, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Health in people with Type 2 Diabetes and PreDiabetes, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) - Post-Test (time frame: post-test (immediately after completion of 6 week intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.